SR Software Quality Engineer - Medical Devices

Talented Engineer with a background in Software Quality needed to join Gilero's team where we help bring life-enhancing products to market efficiently and effectively. You will be responsible for leading software quality project and company activities for medical device and drug delivery applications. directing, managing, and maintaining the development, validation and control of medical device software products, such as embedded software (SiMD), applications, and software as a medical device (SAMD).

You will lead embedded software project activities for medical device and drug delivery applications.

Gilero is a trusted partner for medical and drug delivery device development, offering expertise in design, development, and manufacturing solutions. We have a passion for innovation and a commitment to excellence with a broad range of projects and technical expertise. Join our team and contribute to improving lives worldwide.

• Lead medical device software quality and test team activities internally and externally.
• Lead software verification and validation activities for products under development in accordance with company procedures.
• Author and approve software test case protocols and reports, software development plans, and other system/software documentation.
• Lead software development projects from product classification, software requirements, development, verification and validation through regulatory clearance.
• Participates and leads software unit, integration, and system verification testing.
• Has experience reviewing Software Architecture and Software Design documentation.
• Provide Quality oversight of software plans, software development, verification, maintenance, and storage.
• Perform risk evaluation and associated management activities related to software development including hazard analysis, FMEA, product risk analysis and mitigation, software safety classification, and basic or enhanced documentation.
• Perform risk evaluation and associated activities related to medical device cybersecurity including threat model, cybersecurity risk analysis and evaluation, including cybersecurity design controls.
• Prepare documentation for regulatory filings, including technical file and 510(K).
• Provide mentorship and guidance to engineers involved in software quality activities.
• Support Gilero’s growth through scaling internal and external software quality resources.
• Identify and implement improvements to the Quality Management System, software development lifecycle and testing practices within the company.
• Participate as team member on new product development projects as quality function representative, and provide support for product and process development activities.
• Maintain a strong, collaborative partnership with cross functional team members.
• Lead internal corrective and preventative actions (CAPA) process and perform effectiveness checks as appropriate, as needed.
• Perform process validations (IQ/OQ), as applicable, including test or other equipment utilizing software, user controls and data management, as needed.
• Support internal and external audits, as needed.
• Support non-product software validation by assessing the need for validation, preparing test scripts and executing protocols, writing reports and other documentation, as required.
• Support company compliance to 21
  
  CFR Part 11 compliance and data integrity policies.

• Minimum:
• Bachelor's degree in engineering, science, or relevant field
• 5-10 years in regulated manufacturing and/or development environment
• Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management system and requirements for medical devices and combination product development and manufacturing
• Expert with IEC 60601-1, IEC 62304, and FDA software development guidelines.
• Expert using risk analysis and continuous improvement concepts
• Extensive experience with GxP requirements
• Strong technical written and verbal communication skills
• Experience leading and/or supporting audits
• Preferred:
• Master's or advanced degree in relevant field
• 10+ years in pharma or medical device manufacturing and/or development environment
• Excellent interpersonal, change management, planning and…